Positive results from phase 2 trial with oral GLP-1 analogue

Feb. 23, 2015 - news

A phase 2 trial with an oral formulation of the long-acting GLP-1 analogue semaglutide in people with type 2 diabetes has been completed successfully.
The trial investigated dose range, escalation, efficacy and safety of once-daily oral semaglutide (OG217SC) compared with oral placebo or once-weekly subcutaneously administered semaglutide in around 600 patients with type 2 diabetes treated for 26 weeks.

Patients who were treated with oral semaglutide in five different doses ranging from 2.5 mg to 40 mg achieved dose-dependent improvements in HbA1c of 0.7% to 1.9% (from a mean baseline HbA1c of 7.9%) after 26 weeks.
Patients treated with a dose of 1mg semaglutide subcutaneously or placebo achieved improvements of 1.9% and 0.3%, respectively.
All doses of oral semaglutide were statistically significantly superior to placebo, which confirmed the primary end-point of the trial.

From a mean baseline weight of 92 kg, patients treated with the highest doses of oral semaglutide experienced a comparable weight loss as patients treated with semaglutide subcutaneously (about 6.5 kg), whereas patients treated with placebo experienced a weight loss of just over 1 kg.
Semaglutide appeared to have a safe and well-tolerated profile in the trial. The most common adverse events were related to the gastrointestinal system, primarily nausea and vomiting. The gastrointestinal adverse events diminished over time, appeared to be dose-dependent and were more prevalent for the highest doses of oral semaglutide compared to subcutaneous semaglutide. No other apparent differences between the treatment groups were observed with respect to overall adverse events and standard safety parameters.

Based on these results, Novo Nordisk will consult with regulatory authorities, whereafter a decision of whether to progress OG217SC into phase 3 development will be made.